Systems and methods to monitor proper disinfection of needleless connectors

ABSTRACT

A device and method for disinfecting a needleless connector, the device including a housing comprising a hub rotationally coupled to a motor, the motor being operably connected to a power source, the hub further comprising a receptacle configured to receive a cleaning head, wherein the device is configured to detect achievement of one or more minimum thresholds which are recommended to achieve proper disinfection of the needleless connector. Various devices and methods are further provided to permit tracking and reporting of disinfection events.

RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.13/904,285, filed May 29, 2013, titled SYSTEMS AND METHODS TO MONITORPROPER DISINFECTION OF NEEDLELESS CONNECTORS, which claims priority toU.S. Provisional Patent Application Ser. Nos. 61/653,926, filed May 31,2012, titled SYSTEMS AND METHODS FOR DISINFECTING NEEDLELESS CONNECTORS;61/653,938, filed May 31, 2012, titled DISPOSABLE DISINFECTION CLEANINGHEAD; 61/653,943, filed May 31, 2012, titled SYSTEMS AND METHODS TOCONTROL PROPER DISINFECTION OF NEEDLELESS CONNECTORS; and 61/653,949,filed May 31, 2012, titled SYSTEMS AND METHODS TO MONITOR PROPERDISINFECTION OF NEEDLELESS CONNECTORS, which are incorporated herein intheir entirety.

BACKGROUND OF THE INVENTION

The present invention relates to systems and methods for disinfecting aneedleless connector. In particular, the present invention relates to adisinfection device comprising monitoring and feedback circuitry whichmonitors various minimum thresholds to ensure proper contact between aneedleless connector and a cleaning head of the disinfection device. Insome instances, a disinfection device further comprises a statusindicator which communicates a status or level of disinfection of theneedleless connector to a user.

One of the major challenges of modern medical treatment is control ofinfection and the spread of microbial organisms. One area where thischallenge is constantly presented is in infusion therapy of varioustypes. Infusion therapy is one of the most common health careprocedures. Hospitalized, home care, and other patients receive fluids,pharmaceuticals, and blood products via a vascular access deviceinserted into the vascular system. Infusion therapy may be used to treatan infection, provide anesthesia or analgesia, provide nutritionalsupport, treat cancerous growths, and maintain blood pressure and heartrhythm, or many other clinically significant uses.

Infusion therapy is facilitated by an intravenous (IV) administrationset. The IV administration set may access a patient's peripheral orcentral vasculature. The IV administration set may be indwelling forshort term (days), moderate term (weeks), or long term (months toyears). The IV administration set may be used for continuous infusiontherapy or for intermittent therapy.

A common component of an IV administration set is a plastic catheterthat is inserted into a patient's vein. The IV administration set mayfurther include various connectors and fittings with further facilitateintravenous access and communication. For example, an IV administrationset may include a needleless Luer adapter to which other medical devicesmay be attached. Commonly, an IV administration set comprises one ormore vascular access devices that may be attached to another vascularaccess device, closes the vascular access device, and allows forintermittent infusion or injection of fluids and pharmaceuticals. An IVadministration set may further include a housing and a septum forclosing the system. The septum may be opened with a needlelessconnector, such as a blunt cannula or a male Luer of a medical device.

An IV administration set may serve as a nidus of infection, resulting ina disseminated BSI (blood stream infection). In some instances, this maybe caused by insufficient disinfection of the various connectors andother access components of the IV administration set. Generally,disinfection of needleless connectors and other access components of theIV administration set is accomplished through manual scrubbing using adisinfection swab or pad. However this process varies greatly fromclinician to clinician both in terms of duration and contact forces.These variations lead to inconsistent disinfection which may encouragebacterial growth and infection. Further, the methods are untraceable andtherefore lack the ability to monitor which needleless connectors havebeen disinfected.

Thus, while techniques currently exist that are used for disinfectingneedleless connectors and other access components of an IVadministration set, challenges still exist. Accordingly, it would be animprovement in the art to augment or even replace current techniqueswith other techniques.

BRIEF SUMMARY OF THE INVENTION

The present invention relates to systems and methods for disinfecting aneedleless connector, PRN, or other access components of an IVadministration set. In particular, the present invention relates to adisinfection device comprising monitoring and feedback circuitry whichmonitors various minimum thresholds to ensure proper contact time andpressure between a needleless connector and a cleaning head of thedisinfection device. In some instances, a disinfection device furthercomprises a status indicator which communicates a status or level ofdisinfection of the needleless connector to a user.

Some implementations of the present invention provide a device fordisinfecting a needleless connector of an IV administration set, whereinthe disinfection device includes a housing in which is housed a hubrotationally coupled to a motor. The motor is further operably connectedto a power source, such as an internal battery. In some instances, thehub further includes a receptacle or socket configured to receive acleaning head. In some implementations, the cleaning head comprises adisposable unit. The disinfection device further includes apressure-sensitive switch which is positioned and configured to detect apressure between the cleaning head and a needleless connector, thepressure-sensitive switch comprising a minimum pressure threshold thatmust be met or exceeded to activate the motor.

A disinfection device of the present invention may further include astatus indicator which is configured to display a disinfection status ofthe needleless connector. In some instances, the status indicatorincludes one or more lights which display a color or lighted pattern toindicate the status of disinfection.

Various aspects of the present invention include one or more minimumthresholds which must be met or accomplished to achieve complete orsatisfactory disinfection of the needleless connector. In someinstances, the motor comprises a minimum rotational threshold. In otherinstances, the axial load-sensitive switch comprises a minimum axialload threshold, wherein the minimum axial load threshold is a minimumaxial load between the cleaning head of the disinfection device and theneedleless connector to achieve complete disinfection. In someinstances, the axial load can be the axial force or pressure.

Some implementations of the present invention further include a motorthat is capable of oscillatory rotational motions at certain frequenciessuch that the cleaning head with disinfect the needleless connector in aback and forth motion.

Some implementations of the present invention further include a timerwhich is configured to measure a lapse or length of time over which theminimum threshold is maintained. In some instances, the timer isoperably connected to the status indicator, such that upon detectingcompletion of a minimum time lapse threshold, the timer signals to thestatus indicator that is sufficient disinfection has been achieved. Inturn, the status indicator provides a signal to indicate completedisinfection.

Some aspects of the present invention further include a method forcontrolling proper disinfection of a needleless connector the methodincluding steps for 1) providing a disinfecting device comprising aminimum threshold to indicate a proper interaction between thedisinfecting device and a needleless connector; 2) detecting the minimumthreshold; 3) detecting a minimum disinfection time threshold of thedisinfecting device; and 4) indicating a status of disinfection. Forsome methods, the minimum threshold comprises a minimum rotationaltorque of a motor of the disinfecting device. For other methods, theminimum threshold comprises a minimum pressure threshold of apressure-sensitive switch of the disinfecting device. Further, for somemethods the minimum pressure threshold indicates proper pressure betweenthe cleaning head and the needleless connector. In some instances, theminimum rotational torque is determined by a minimum current of themotor.

Some aspects of the present invention further include a method fordetermining proper disinfection of a needleless connector, the methodincluding steps for 1) sensing a minimum contact threshold between theneedleless connector and a cleaning head of a disinfecting device; 2)sensing a length of time for which the minimum contact threshold ismaintained; and 3) indicating a status of disinfection based upon thelength of time for which the minimum contact threshold is maintained.

Some implementations of the present invention further include a devicefor disinfecting a needleless connector, the device comprising a housinghaving a hub rotationally coupled to a motor, the motor being operablyconnected to a power source the hub further including a receptacleconfigured to receive a cleaning head, the device further including apressure-sensitive switch configured to detect a pressure between thecleaning head and the needleless connector, the pressure-sensitiveswitch comprising a minimum pressure threshold that must be met orexceeded to activate the motor. The device further includes an input forreceiving an identification of the needleless connector and/or thecleaning head, and an output for communicating the identification and adisinfection status of the needleless connector and/or the cleaninghead. The tracking of the cleaning head can be important in case wherethe cleaning head is to be used only once. In some instances, the outputcomprises at least one of a wireless antenna, an electrical connector,an RFID transmitter, and a Bluetooth transmitter. In other instances,the input comprises at least one of a barcode scanner, an opticalcamera, and a magnetic card reader. The disinfection device furthercomprises a network operably connected to the output whereby informationretrieved by the disinfection device is transferred to a remote computerdevice and subsequently stored in electronic medical record of thepatient for whom the needleless connector was disinfected.

Some aspects of the present invention further include a method formonitoring and recording disinfection information of a needlelessconnector, the method including steps for 1) receiving a disinfectionstatus from a disinfection device; 2) receiving and identification ofthe needleless connector; 3) sending the disinfection status and theidentification of the needleless connector to a remote computer system;and 4) storing the disinfection status and the identification of theneedleless connector in an electronic medical record. The method furtherincludes a step for receiving and identification of a patient associatedwith the needleless connector.

Some implementations of the present invention further include a methodfor monitoring and recording a disinfection event of a needlelessconnector, the method including steps for 1) attaching a disposablecleaning head to a rotor of a disinfection device; 2) using thedisinfection device to record and identification of the needlelessconnector; 3) using the disinfection device to record an identificationof a patient; 4) disinfecting the needleless connector; 5) recordingcompletion of the disinfection of the needleless connector; and 6)updating an electronic medical record of the patient to include thedisinfection event. The method further includes a step for tracking thedisposable cleaning head to ensure that the disposable cleaning head isused for only one disinfection event. The method may further includesteps for internally recording the disinfection event into a memory ofthe disinfection device; and linking the cleaning event to the identityof the patient.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

In order that the manner in which the above-recited and other featuresand advantages of the invention are obtained will be readily understood,a more particular description of the invention briefly described abovewill be rendered by reference to specific embodiments thereof which areillustrated in the appended drawings. These drawings depict only typicalembodiments of the invention and are not therefore to be considered tolimit the scope of the invention.

FIG. 1 shows a flow chart of a representative system that provides asuitable operating environment in which various embodiments of thepresent invention may be implemented.

FIG. 2 shows a flow chart of a representative networking system thatprovides a suitable environment in which various embodiments of thepresent invention may be implemented.

FIG. 3 is a perspective view of a handheld disinfection device inaccordance with a representative embodiment of the present invention.

FIG. 4 is a cross-section top view of the handheld disinfection deviceshown in FIG. 3 in accordance with a representative embodiment of thepresent invention.

FIG. 5 is a cross-section top view of a disinfection device inaccordance with a representative embodiment of the present invention.

FIG. 6 is a flowchart demonstrating a method for controlling properdisinfection of a needleless connector in accordance with arepresentative embodiment of the present invention.

FIG. 7 is a flowchart demonstrating a method for controlling properdisinfection of a needleless connector in accordance with arepresentative embodiment of the present invention.

FIG. 8 is a cross-section view of a disinfection cleaning head and aneedleless connector in accordance with a representative embodiment ofthe present invention.

FIG. 9 is a perspective view of a representative cleaning head and hubreceptacle having attachment arm shown in phantom in accordance with arepresentative embodiment of the present invention.

FIG. 10 is a cross-section view of a cleaning head and hub receptacle,prior to insertion of the cleaning head, in accordance with arepresentative embodiment of the present invention.

FIG. 11 is a cross section view of a cleaning head and hub receptacle,after insertion of the cleaning head, in accordance with arepresentative embodiment of the present invention.

FIG. 12 is a cross section view of a cleaning head and hub receptacle,after ejection of the cleaning head, in accordance with a representativeembodiment of the present invention.

FIG. 13 is a perspective view of a handheld disinfection device furthercomprising input and output features in accordance with a representativeembodiment of the present invention.

FIG. 14 is a cross-section top view of the handheld disinfection deviceof FIG. 8 in accordance with a representative embodiment of the presentinvention.

FIG. 15 is a diagrammatic view of a handheld disinfection deviceoperably connected to an electronic medical record via a network inaccordance with a representative embodiment of the present invention.

FIG. 16 is a diagrammatic view of a handheld disinfection deviceoperably connected to an electronic medical record via a computer deviceand a network in accordance with a representative embodiment of thepresent invention.

FIG. 17 is a diagrammatic view of a handheld disinfection devicedemonstrating various input and output features in accordance with arepresentative embodiment of the present invention.

FIG. 18 is a flowchart demonstrating a method for monitoring, recordingand tracking disinfection information in accordance with arepresentative embodiment of the present invention.

FIG. 19 is a flowchart demonstrating a method for monitoring andrecording a disinfection event of a needleless connector in accordancewith a representative embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The presently preferred embodiments of the present invention will bebest understood by reference to the drawings, wherein like referencenumbers indicate identical or functionally similar elements. It will bereadily understood that the components of the present invention, asgenerally described and illustrated in the figures herein, could bearranged and designed in a wide variety of different configurations.Thus, the following more detailed description, as represented in thefigures, is not intended to limit the scope of the invention as claimed,but is merely representative of presently preferred embodiments of theinvention.

In general, the present invention relates to systems and methods fordisinfecting a needleless connector. In particular, the presentinvention relates to a disinfection device comprising monitoring andfeedback circuitry which monitors various minimum thresholds to ensureproper contact between a needleless connector and a cleaning head of thedisinfection device. In some instances, a disinfection device furthercomprises a status indicator which communicates a status or level ofdisinfection of the needleless connector to a user.

As used herein, the term “threshold” is used to denote a minimum value,level, or point which is required to achieve sufficient disinfection ofa needleless connector. In some instances, the term “threshold” is usedto denote a minimum axial load needed to activate an axialload-sensitive switch. In other instances, the term “threshold” is usedto denote a minimum pressure between a cleaning head of the disinfectiondevice and a surface of a needleless connector. Further, in someinstances the term “threshold” is used to denote a minimum length oftime required to achieve disinfection of a needleless connector. Furtherstill, in some instances the term “threshold” is used to denote aminimum rotational torque of a motor of a disinfection device. In otherinstances, the term “threshold” is used to denote a minimum length oftime required to achieve a certain rotational speed of the motor.

As used herein, the term “disinfection” is used to denote a level ofsanitation which is free from infection or free from microorganismswhich are capable of promoting infection in the patient.

As used herein, the term “disinfectant” is used to denote an agent thatdestroys vegetative forms of harmful microorganisms such as bacteria,fungi, yeasts, viruses and other harmful pathogens.

As used herein, the term “needleless connector” is used to denote amedical coupler which is used as part of an intravenous assembly. Insome instances, a needleless connector comprises a Luer adapter. Inother instances, a needleless connector comprises a PRN connector. Anexample of a needleless connector is the Q-Syte™ luer access port fromBecton, Dickinson. Further, in some instances a needleless connectorcomprises a port or valve of a section of intravenous tubing or aconnector thereof. One having skill in the art will appreciate that thesystems and methods of the present invention may be adapted for use withvarious other types of connectors and other devices for which automateddisinfection is desirable.

As used herein, the term “disinfection event” denotes a process by whicha disinfection device is used to disinfect a needleless connector, inaccordance with the teachings of the present invention. In someinstances, a disinfection event is preceded by collecting informationregarding the patient and/or the needleless connector via an inputinterface of the disinfection device. The identifying information may betemporarily stored within memory of the disinfection device for latertransmission to a remote computer device, or may be transferred to aremote computer device in real-time.

FIGS. 1 and 2, and the corresponding discussion, provide a generaldescription of a suitable operating environment in which embodiments ofthe invention may be implemented. One skilled in the art will appreciatethat embodiments of the invention may be practiced by one or morecomputing devices and in a variety of system configurations, includingin a networked configuration. However, while the methods and processesof the present invention have proven to be particularly useful inassociation with a system comprising a general purpose computer,embodiments of the present invention include utilization of the methodsand processes in a variety of environments, including embedded systemswith general purpose processing units, digital/media signal processors(DSP/MSP), application specific integrated circuits (ASIC), stand aloneelectronic devices, and other such electronic environments.

Embodiments of the present invention embrace one or more computerreadable media, wherein each medium may be configured to include orincludes thereon data or computer executable instructions formanipulating data. The computer executable instructions include datastructures, objects, programs, routines, or other program modules thatmay be accessed by a processing system, such as one associated with ageneral-purpose computer capable of performing various differentfunctions or one associated with a special-purpose computer capable ofperforming a limited number of functions. Computer executableinstructions cause the processing system to perform a particularfunction or group of functions and are examples of program code meansfor implementing steps for methods disclosed herein. Furthermore, aparticular sequence of the executable instructions provides an exampleof corresponding acts that may be used to implement such steps. Examplesof computer readable media include random-access memory (“RAM”),read-only memory (“ROM”), programmable read-only memory (“PROM”),erasable programmable read-only memory (“EPROM”), electrically erasableprogrammable read-only memory (“EEPROM”), compact disk read-only memory(“CD-ROM”), or any other device or component that is capable ofproviding data or executable instructions that may be accessed by aprocessing system.

With reference to FIG. 1, a representative system for implementingembodiments of the invention includes computer device 10, which may be ageneral-purpose or special-purpose computer. For example, computerdevice 10 may be a personal computer, a notebook computer, a personaldigital assistant (“PDA”) or other hand-held device, a workstation, aminicomputer, a mainframe, a supercomputer, a multi-processor system, anetwork computer, a processor-based consumer electronic device, a smartphone, a position identifier, a ball collector, or the like.

Computer device 10 may include a system bus 12, which may be configuredto connect various components thereof and enables data to be exchangedbetween two or more components. System bus 12 may include one of avariety of bus structures including a memory bus or memory controller, aperipheral bus, or a local bus that uses any of a variety of busarchitectures. Typical components connected by system bus 12 includeprocessing system 14 and memory 16. Other components may include one ormore mass storage device interfaces 18, input interfaces 20, outputinterfaces 22, and/or network interfaces 24, each of which will bediscussed below.

Processing system 14 includes one or more processors, such as a centralprocessor and optionally one or more other processors designed toperform a particular function or task. It is typically processing system14 that executes the instructions provided on computer readable media,such as on memory 16, a magnetic hard disk, a removable magnetic disk, amagnetic cassette, an optical disk, thumb drives, solid state memory, auniversal serial bus or from a communication connection, which may alsobe viewed as a computer readable medium.

Memory 16 includes one or more computer readable media that may beconfigured to include or includes thereon data or instructions formanipulating data, and may be accessed by processing system 14 throughsystem bus 12. Memory 16 may include, for example, ROM 28, used topermanently store information, and/or RAM 30, used to temporarily storeinformation. ROM 28 may include a basic input/output system (“BIOS”)having one or more routines that are used to establish communication,such as during start-up of computer device 10. RAM 30 may include one ormore program modules, such as one or more operating systems, applicationprograms, and/or program data.

One or more mass storage device interfaces 18 may be used to connect oneor more mass storage devices 26 to system bus 12. The mass storagedevices 26 may be incorporated into or may be peripheral to computerdevice 10 and allow computer device 10 to retain large amounts of data.Optionally, one or more of the mass storage devices 26 may be removablefrom computer device 10. Examples of mass storage devices include harddisk drives, magnetic disk drives, thumb drive tape drives and opticaldisk drives. A mass storage device 26 may read from and/or write to amagnetic hard disk, a removable magnetic disk, a magnetic cassette, anoptical disk, or another computer readable medium. Mass storage devices26 and their corresponding computer readable media provide nonvolatilestorage of data and/or executable instructions that may include one ormore program modules such as an operating system, one or moreapplication programs, other program modules, or program data. Suchexecutable instructions are examples of program code means forimplementing steps for methods disclosed herein.

One or more input interfaces 20 may be employed to enable a user toenter data and/or instructions to computer device 10 through one or morecorresponding input devices 32. Examples of such input devices include akeyboard and alternate input devices, such as a mouse, trackball, lightpen, stylus, or other pointing device, a microphone, a joystick, a gamepad, a satellite dish, a scanner, a camcorder, a digital camera, and thelike. Similarly, examples of input interfaces 20 that may be used toconnect the input devices 32 to the system bus 12 include a serial port,a parallel port, a game port, a universal serial bus (“USB”), anintegrated circuit, a firewire (IEEE 1394), or another interface. Forexample, in some embodiments input interface 20 includes an applicationspecific integrated circuit (ASIC) that is designed for a particularapplication. In a further embodiment, the ASIC is embedded and connectsexisting circuit building blocks.

One or more output interfaces 22 may be employed to connect one or morecorresponding output devices 34 to system bus 12. Examples of outputdevices include a monitor or display screen, a speaker, a printer, amulti-functional peripheral, and the like. A particular output device 34may be integrated with or peripheral to computer device 10. Examples ofoutput interfaces include a video adapter, an audio adapter, a parallelport, and the like.

One or more network interfaces 24 enable computer device 10 to exchangeinformation with one or more other local or remote computer devices,illustrated as computer devices 36, via a network 38 that may includehardwired and/or wireless links. Examples of network interfaces includea network adapter for connection to a local area network (“LAN”) or amodem, wireless link, or other adapter for connection to a wide areanetwork (“WAN”), such as the Internet. The network interface 24 may beincorporated with or peripheral to computer device 10. In a networkedsystem, accessible program modules or portions thereof may be stored ina remote memory storage device. Furthermore, in a networked systemcomputer device 10 may participate in a distributed computingenvironment, where functions or tasks are performed by a plurality ofnetworked computer devices.

Thus, while those skilled in the art will appreciate that embodiments ofthe present invention may be practiced in a variety of differentenvironments with many types of system configurations, FIG. 2 provides arepresentative networked system configuration that may be used inassociation with embodiments of the present invention. Therepresentative system of FIG. 2 includes a computer device, illustratedas client 40, which is connected to one or more other computer devices(illustrated as client 42 and client 44) and one or more peripheraldevices (illustrated as multifunctional peripheral (MFP) MFP 46) acrossnetwork 38. While FIG. 2 illustrates an embodiment that includes aclient 40, two additional clients, client 42 and client 44, oneperipheral device, MFP 46, and optionally a server 48, connected tonetwork 38, alternative embodiments include more or fewer clients, morethan one peripheral device, no peripheral devices, no server 48, and/ormore than one server 48 connected to network 38. Other embodiments ofthe present invention include local, networked, or peer-to-peerenvironments where one or more computer devices may be connected to oneor more local or remote peripheral devices. Moreover, embodiments inaccordance with the present invention also embrace a single electronicconsumer device, wireless networked environments, and/or wide areanetworked environments, such as the Internet.

Referring now to FIG. 3, an implementation of a disinfection device 100is shown. In some embodiments, a disinfection device 100 is provided asa handheld unit, wherein the disinfection device comprises a housing 102which is sized and configured to be held in the hand of the user duringdisinfection of a needleless connector 120. Housing 102 of disinfectiondevice 100 may include any size, shape and/or configuration as may bedesirable. For example, in some embodiments disinfection device 100comprises a stationary tabletop unit.

In some embodiments, housing 102 of disinfection device 100 furthercomprises one or more status indicators 104 which indicate a level ofdisinfection of needleless connector 120. For example, in some instancesstatus indicators 104 comprise one or more lights 106 which areconfigured to provide information to a user. In some instances, lights106 may blink to indicate a stage or level of disinfection forneedleless connector 120. Lights 106 may further comprise two or morecolors, wherein a color indicates a stage or level of disinfection forneedleless connector 120. For example, in some embodiments a red lightindicates incomplete or unsatisfactory disinfection of needlelessconnector 120. Further, a yellow light may indicate an intermediary oractive process of disinfection for needleless connector 120. Furtherstill, a green light may indicate a satisfactory or completedisinfection for needleless connector 120. In some instances, theindicators can be at least one of the LED screen with text, symbols,instruction, animation with both visual and audible alert includingtone, buzz, and or speech.

Lights 106 may further be programmed to blink or otherwise demonstratesa lighted pattern to further communicate a status of disinfection device100. For example, in some embodiments lights 106 may be programmed todemonstrate a lighted pattern to indicate a low battery. Lights 106 mayfurther be programmed to demonstrate an error or mechanical malfunction.In some instances, lights 106 may be programmed to indicate thatdisinfection device 100 is ready to receive needleless connector 120.

In some embodiments, disinfection device 100 comprises a cleaning head108 which is positioned on housing 102 at a location which facilitateseasy access for needleless connector 120. In some instances, cleaninghead 108 is positioned opposite of status indicators 104 therebypermitting the user to access cleaning head 108 with needlelessconnector 120 while maintaining visualization a status indicators 104.Cleaning head 108 may be accessed as a user holds disinfection device100 in their hand 110 while aligning and contacting needleless connector120 with cleaning head 108 using the user's other hand 112. Followingdisinfection, the user removes needleless connector 120 from cleaninghead 108 thereby completing the disinfection process.

Referring now to FIG. 4, a cross-section top view of disinfection device100 is shown. In some embodiments, housing 102 comprises an interior 130in which is housed various components of the device. For example,interior 130 houses a motor 140 which is rotatably connected to a rotor142 via a motor shaft 144. Rotor 142 is positioned within a distalopening 132 of housing 102 such that a socket or receptacle 146 isaccessible to the user. Receptacle 146 is sized and configured tocompatibly receive and retain a post portion 114 of cleaning head 108.In some embodiments, cleaning head 108 is disposable. In otherembodiments, cleaning head 108 is reusable. In other embodiment, thecleaning head can be one of the commercially available disinfecting heador cap. Cleaning head 108 further comprises an opening 116 having alength and diameter to compatibly receive needleless connector 120.Opening 116 further comprises a cleaning pad 118 which may be soaked orotherwise preloaded with a cleaning agent or disinfectant. In someinstances, a disinfectant is loaded onto cleaning pad 118 prior tointroducing needleless adapter 120 into opening 116.

Motor 140 is generally provided as a means for rotating rotor 142 abouta central axis defined by motor shaft 144. In some instances,disinfection device 100 further comprises a speed control (not shown)whereby to regulate the speed at which motor 140 rotates rotor 142. Inother instances, the speed at which rotor 142 rotates is affected by afriction between needleless connector 120 and cleaning pad 118. Someimplementations of the present invention further comprise an electronicspeed control (not shown) which controls the rotational speed of rotor142 such that rotor 142 rotates at a constant speed regardless offriction between needleless connector 120 and cleaning pad 118.

Motor 140 may comprise any type or size of motor compatible with variousembodiments of the present invention. For example, in some instancesmotor 140 comprises a DC motor which is powered by an internal battery150. In other instances, motor 140 comprises an AC motor which ispowered by an external power source (not shown). Motor 140 may furtherinclude a unidirectional rotation motion, a bidirectional rotationmotion, or an oscillatory rotation motion.

Disinfection device 100 may further comprise a printed circuit board 160which comprises various monitoring and feedback circuitry to controlproper disinfection of needleless connector 120. For example, in someembodiments printed circuit board 160 comprises a speed sensor 162 whichis configured to monitor and measure the rotational speed of rotor 142.Printed circuit board 160 may further comprise a status indicatorcontroller 170 Speed sensor 162 monitors and measures the actualrotation speed of rotor 142 to determine whether a minimum axialrotation speed threshold is maintained by disinfection device 100 duringdisinfection of needleless connector 120.

Where speed sensor 162 measures an axial rotation speed for rotor 142that is less than a minimum axial rotation speed, speed sensor 162 maygenerate an error code which is received by status indicator controller164. Controller 164 may then send a signal to status indicator 104 whichmay cause light 106 to blink, display a color, or other lighted patternto indicate insufficient axial rotation speed. In some instances, statusindicator 104 comprises multiple lights (shown in phantom) to permitvarious combinations of light patterns and other signals or LCD screensthat provide picture, text, animation, and audible feedback. Where aminimum axial rotation speed threshold is known, axial rotation speedsthat are less than the minimum axial rotation speed threshold provideinsufficient disinfection for needleless connector 120. Accordingly, auser may be required to lessen friction between needleless connector 120and cleaning head 108 to permit a minimally acceptable axial rotationspeed.

In some embodiments, another sensor 164 measures the actual rotationaltorque of rotor 142 and/or motor shaft 144. The disinfection action ofthe present invention involves friction contact between needlelessconnection 120 and cleaning pad 118. Such friction generates resistanceto the rotational motion of motor 140, or torque loading on the motor.This torque load is proportional to the motor current required to rotatemotor 140 at the minimum rotational speed threshold. Thus, in someembodiments sensor 164 measures rotational torque of rotor 142 bymeasuring the current of motor 140. As the load of motor 140 increases(such as by increasing friction between needleless connector 120 andcleaning head 108), so does the current of motor 140. In some instances,sensor 164 monitors the current of motor 140 to detect fluctuations inthe current of motor 140 which may suggest a load that is prohibitingattainment of the minimum rotation speed threshold. Speed sensor 162 maythen generate an error code for the user. In other instances, speedsensor 162 may allow additional amperage to motor 140 to compensate foran increased load, thereby maintaining the minimal axial rotation speedthreshold for rotor 142. In yet other instance, the speed sensor 162would increase the time the disinfection action is taking to ensureproper disinfection duration. Accordingly, some embodiments of thepresent invention provide a system that monitors the torque of motor 140and sets a low threshold limit, thereby making it possible to guaranteeproper engagement and/or pressure between cleaning head 108 andneedleless connector 120, thus ensuring proper disinfection of connector120.

In an alternative embodiment, an axial force on motor 140 may bemeasured with a load cell. Such force would correlate to the contactpressure between needleless connector 120 and cleaning head 108. Aminimum threshold may thus be set on this axial force andmonitored/reported by printed circuit board 160 and status indicator104.

Printed circuit board 160 may further comprise a timer 170 whereby tomeasure a time lapse or interval over which the minimum rotation speedthreshold is maintained by rotor 142. In some instances, sufficientdisinfection is a factor of minimum rotation speed and time. Forexample, in some embodiments complete disinfection requires that theminimum axial rotation speed threshold be maintained for a minimallength of time, such as 15 seconds. Thus, timer 170 is configured tomeasure the length of time for which the minimum axial rotation speedthreshold is maintained during disinfection of needleless connector 120.In some instanced, constant sustainment of the minimum axial rotationspeed threshold is required for a determined length of time. In otherinstance, intermittent sustainment of the minimum axial rotation speedthreshold for a cumulative length of time is sufficient for completedisinfection. Thus, timer 170 may be configured to measure axialrotation and time as may be determined to achieve complete disinfection.

In some embodiments, the timer 170 is used to also monitor the time forthe motor to reach certain minimum rotational speed. Since the propercontact between the needleless connector and the cleaning head wouldgenerate certain friction, the time it takes for the motor to reachcertain rotational speed will be increase comparing to the cases wherethe needleless connector is absent. Making sure the time to reachcertain rotational speed is greater than a minimum value would ensureproper engagement and disinfection of the needleless connector. Thisapproach could be used preferably when oscillatory rotational cleaningmotion is used.

Referring now to FIG. 5, in some embodiments disinfection device 200further comprises a pressure-sensitive switch 210 which is interposedlypositioned between post 114 of cleaning head 108 and receptacle 146.Switch 210 may be positioned at any location within disinfection device200 or cleaning head 108 which is capable of measuring a contactpressure between needleless connector 120 and cleaning pad 118. Forexample, device 100 may comprise a spring (not shown) on which motor 140is mounted, wherein upon establishing contact between cleaning head 108and connector 120, the spring is compressed thereby engaging a switchwhich completes a circuit between motor 140 and battery 150 to causemotor 140 to rotate.

Switch 210 is provided to measure pressure between needleless connector120 and cleaning pad 118. Some embodiments of the present inventioncomprises a known minimum pressure which must be attained betweenneedleless connector 120 and cleaning pad 118 to achieve completedisinfection. Accordingly, switch 210 measures pressure betweenconnection 120 and pad 118 by measuring pressure between post 114 andswitch 210. Upon initial contact between connector 120 and cleaning pad118, pressure-sensitive switch 210 is activated thereby causing motor140 to rotate rotor 142 and cleaning head 108. As contact pressurebetween connection 120 and pad 118 increases and exceeds a minimumpressure threshold, switch 210 signals pressure sensor 220 that theminimum threshold has been reached. In some instances, timer 170monitors the length of time over which the minimum threshold ismaintained. Following sufficient disinfection, signal indicator 104provides a signal to the user indicating that complete disinfection hasbeen attained.

Referring now to FIG. 6, a flowchart for a computer software program inaccordance with a representative embodiment of the present invention isshown. In some embodiments, a computer software program is providedhaving computer executable instructions to detect the presence of aneedleless connector (at step 600). As discussed above, the disinfectiondevice may be provided having hardware that attacks the physicalpresence of a needleless connector, such as a pressure-sensitive switch.Some embodiments of the present invention further comprise adisinfection device having a light sensor or other type of sensor whichis configured to detect the presence of needleless connector in contactwith a cleaning head of the device.

Once a needleless connector is detected (at step 602), the computerexecutable instructions then detect a minimum threshold of thedisinfection device (at step 604). As discussed previously, a minimumthreshold may include a minimum pressure (at step 608), a minimum axialrotation speed (at step 606), a minimum disinfection time interval (atstep 610), a combination of one or more minimum thresholds, or otherminimum thresholds which are determined to achieve sufficient orcomplete disinfection of a needleless connector.

Once complete disinfection of a needleless connector is detected (atstep 612), the computer executable instructions then indicate a statusof disinfection (at step 614). As discussed previously, the step ofindicating a status of disinfection may be executed at any stage of thedisinfection process. For example, in some embodiments a status ofdisinfection is provided to indicate completion of disinfection. Inother embodiments, a status of disinfection is provided to indicate anincomplete disinfection. Further, in some embodiments a status ofdisinfection is provided to indicate a proper contact and/or pressurebetween a cleaning head of the disinfection device and a needlelessconnector. In some instances, the computer executable instructionsfurther include a step for reporting a final status of disinfection (atstep 616).

Referring now to FIG. 7, a method for controlling proper disinfection ofa needleless connector in accordance with the present invention isshown. In some embodiments, a method comprises a first step of sensing aminimum contact threshold between a needleless connector and a cleaninghead of a disinfection device (at step 700). A minimum contact thresholdgenerally comprises a minimum pressure or minimum contact between theneedleless connector and the cleaning head of the disinfection device,wherein the minimum contact threshold is determined to achieve orfacilitate complete disinfection of the needleless connector. Uponsensing achievement of the minimum contact threshold (at step 702), alength of time for which the minimum contact threshold is maintained isfurther measured and/or sensed (at step 704). Some methods equatecomplete or sufficient disinfection based upon reaching a minimum lengthof time for which the minimum contact threshold is maintained. In someinstances, the minimum length of time is 15 seconds. In other instances,the minimum length of time is greater than 15 seconds. Further still, insome instances the minimum length of time is less than 15 seconds.

Once the minimum length of time is reached, the status of disinfectionis indicated, for example via a status indicator (at step 708). In someembodiments, a disinfection device is provided which is configured toautomatically stop or turn off once complete or sufficient disinfectionis achieved. In other embodiments, a disinfection device is configuredto provide an audible signal to indicate complete disinfection. Systemsmay further include combinations of audible and visual signals toindicate a status of disinfection. Further still, systems may report afinal status of disinfection.

The present invention may include various structures and featureswhereby to removably coupled the cleaning head to the rotor. Forexample, FIG. 8 illustrates an alternative embodiment of a cleaning head808. Cleaning head 808 includes an inner chamber 816 that engages aportion 122 of needleless connector 120. A part of, or the entire insidesurface of the inner chamber 816 can be lined with an absorbent material818. Absorbent material 818 can include a porous foam material thatexhibits compressible properties. Absorbent material 818 can beimpregnated with a cleaning agent or disinfectant. Non-limiting examplesof disinfectants include alcohol, iodine, and/or a chlorhexidinesolution (e.g., a chlorhexidine gluconate (CHG) solution). In someembodiments, a pad or cloth 820 is coupled to the absorbent material818. Cloth 820 or absorbent material 818 can interface with theneedleless connector 120 during movement of the hub 142 to dispense thedisinfectant on the needleless connector 120 and clean the surface ofneedleless connector 120. Cloth 820 or absorbent material 818 may besmooth or textured to effectively distribute disinfectant and/or providecleaning action about needleless connector 120.

Cloth 820 or absorbent material 818 is configured to interface withneedleless connector 120 when needleless connector 120 is inserted intocleaning head 808. This interaction may be facilitating by sizing theinner chamber 816 to be smaller than the outer dimensions of needlelessconnector 120. For instance, the diameter of inner chamber 116 may besmaller than the outer diameter of needleless connector 120 to allowcloth 820 or absorbent material 818 to contact all exterior sidesurfaces of needleless connector 120, including any threaded surfaces.Additionally, in some embodiments, the depth of inner chamber 816 may beshorter than the length of the needleless connector 120 to allow contactwith all end surface of needleless connector 120. The smaller dimensionsof inner chamber 816 can induce an inward pressure on needlelessconnector 120 and compress absorbent material 818. As absorbent material818 is compressed, disinfectant impregnated within absorbent material818 can migrate to the needleless connector 120. During operation of thedisinfectant device 100, disinfectant in contact with the needlelessconnector 120 can be repeatedly swiped, scrubbed, and moved until itapproximately covers all external surfaces of needleless connector 120.Exposure to the disinfectant along with the movement of the cleaninghead 808 for a predetermined period of time can substantially disinfectthe entire needleless connector 120.

In some embodiments, cleaning head 808 further includes one or moreattachment features 802 that can be used to selectively couple cleaninghead 808 to the hub 142. As shown, attachment features 802 can includean indent, an annular or partial recess or groove, or other depressionthat can be clasped or otherwise attached to the hub 142. Conversely,attachment features 802 can be a protrusion, latch, hook, or other suchstructure. In some embodiments, hub 142 can include a correspondingattachment feature configured to mate with and secure attachmentfeatures 802 of cleaning head 808, as shown in FIG. 9.

FIG. 9 illustrates representative embodiments of attachment features902, 904 of a cleaning head 908, and a hub 942, respectively. As shown,in some embodiments, cleaning head 908 includes a series of indents 902spaced radially about its exterior. Indents 902 can extend entirelythrough a wall or body of cleaning head 908 (e.g., windows in thecleaning head 308) or only partially into the wall or body (e.g., as adepression therein). Indents 902 can be configured to selectivelyinterlock with a hook member 906 of an attachment arm 904 of hub 942.Attachment arms 904 can be coupled to the body of hub 942 and biasedinwardly to apply an inward pressure against cleaning head 908. Thispressure can secure cleaning head 908 in place and deter prematureejection of cleaning head 908 during high-speed rotation that may beexperienced during disinfection operations. Any suitable number ofindents 902 and corresponding attachment arms 904 can be utilized,including 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, or more than 12.Alternatively, a single annular indent (or groove) can replace themultiple indents 902.

In some embodiments, it may be advantageous to enable one-pushattachment of cleaning head 908 into hub 942. Thus, an operatingclinician can insert a new cleaning head 908 into receptacle 146 of hub942 by merely inserting cleaning head 908 therein and applying enoughpressure to interlock attachment arms 904 within indents 902.Accordingly, in some configurations, attachment arms can have inclineddistal surfaces 910 that promote one-push snap-in attachments. Thus, asthe proximal side of cleaning head 908 is pressed against inclineddistal surfaces 910, the force on inclined distal surfaces 910 movesattachment arms 904 outward, permitting entry of cleaning head 908. Ascleaning head 908 is advanced proximally, hook members 906 enter indents902, latching cleaning head 908 within receptacle 146.

In some alternative embodiments, attachment arms 904 and indents 902 canbe replaced with one or more magnets or electromagnets (not shown) thatcan attach and secure cleaning head 908 within receptacle 146.Non-limiting examples of magnets include rare earth magnets. Whenconfigured with one or more electromagnets, cleaning head 908 can beejected or attached detached by switching the electromagnet off and on,respectively. One or more switches can be provided to toggle theelectromagnet power.

Reference will now be made to FIGS. 10 through 12, which illustrate theprocess of attaching and detaching cleaning head 908 to hub 942. Turningfirst to FIG. 10, cleaning head 908 and receptacle 146 having attachmentarms 904 similar to those of FIG. 9 are depicted. As mentioned, due tothe inclined orientation of the proximal end of attachment arms 904,cleaning head 908 may be inserted within receptacle 146 by applying athreshold proximal force thereto. Once cleaning head 908 is proximallyadvanced to the point at which hook members 906 of attachment arms 904insert within indents 902, the cleaning head 908 is secured and preparedfor disinfecting operation, as shown in FIG. 11.

After one or more disinfecting operation, cleaning head 908 may beejected. When detached, cleaning head may remain on a needlelessconnector to act as a physical contamination barrier or disposed of inthe trash. In either case, an operating clinician may not be required tocontact cleaning head 908, which has been used at this point. Rather, insome configurations, the clinician may simply eject cleaning head 908using an ejection button, such as button 110 of FIG. 3.

In some embodiments, as shown in FIGS. 10 and 12, an ejector 1000 isdisposed within a proximal end of receptacle 146. Ejector 1000 may be apiston or other movable structure that can selectively press distallyagainst cleaning head 908 until it is forced out receptacle 146. Thedistal force of ejector 1000 can cause attachment arms 904 and/or hub942 to flex outwardly away from cleaning head 908. As this force issufficiently increased, hook members 906 of attachment arms 904 arereleased from within indents 902 of cleaning head 908, freeing cleaninghead 908 to be ejected from receptacle 146. In some embodiments whichutilize magnetic attachment means, cleaning head 908 may similarly beejected using a manual ejector 1000 or by simply turning off power to anelectromagnet.

From the foregoing, it will be seen that the present disinfecting devicecan disinfect a needleless connector. When a needleless connector is atleast partially inserted within the cleaning head of the disinfectingdevice, disinfectant within the cleaning head may be applied to theexterior surfaces of the needleless connector, preparing it for use.Moreover, a detachable cleaning head can couple to a needlelessconnector after it is detached from the disinfection device to protectthe needleless connector until it is used.

Referring now to FIG. 13, an implementation of a disinfection device1300 is shown. Disinfection device 1300 is similar to disinfectiondevice 100, however disinfection device 1300 further comprises an inputinterface 1310 and an output interface 1320 to facilitate collection andreporting of information related to a cleaning event of disinfectiondevice 1300. For example, in some embodiments input interface 1310comprises a barcode scanner which is capable of reading acomputer-readable barcode that is placed on needleless connector 120,and/or an identification tag or label of the patient. In otherembodiments, input interface 1310 further comprises a magnetic cardreader, or an optical camera which is capable of retrieving informationstored within a magnetic stripe or a computer-readable code,respectively. For example, a patient may have an identification cardhaving a magnetic stripe which contains the identity of the patient andother related medical information. The patient and/or needlelessconnector may further include a QR code which is capable of beingdetected and deciphered using an optical camera and computer-executablesoftware configured to retrieve information from the QR code. In otherembodiments, the patient and/or the needleless connector may furtherinclude an RFID tag which can be read by a RFID reader on thedisinfection device.

Some embodiments of the present invention further comprise a device orcomponent of a device that includes a material, a coating, or a tagcontaining a material or coating that is configured to change color inresponse to prolonged exposure to air and/or a liquid. A color-changingmaterial may be useful in communicating to a user a length of time forwhich the cleaning head and/or needleless connector has been exposed toan unsterile environment. A color-changing material may also be usefulin communicating to a user that the device or component has beenpreviously used. In some instances, a device or component of the presentinvention is packaged in airtight packaging, thereby preserving aninitial color of the color-changing material. Upon opening the airtightpackaging, the color-changing material is exposed to air therebychanging the color of the device or component. This feature may preventa device or component from being reused. This feature may also preventan unsterile device or component from being used.

In some embodiments, information relating to the identity of the patientand the identity of the needleless adapter are retrieved and stored byinput interface 1310 prior to a disinfection event. In some instances,additional information relating to the disinfection event is furthercollected and stored in memory of the disinfection device. For example,disinfection device 1300 may further collect and store information suchas the date and time of the disinfection event, the identity of theclinician, and a final disinfection status of the needleless connector.Following the disinfection event, the collected and stored informationis transferred to a remote computer device via output interface 1320.

Similarly, the information related to the identity of the cleaning headcan be retrieved and stored by the input interface 1310. The collectionof the information on the identity of the cleaning head can beparticularly important where the cleaning head is to be used only once.The disinfection action can be prevented if the cleaning head has beenused previously.

Output interface 1320 may include any type or configuration of outputwhich is capable of transferring stored information from disinfectiondevice 1300 to a remote computer device. For example, in someembodiments output interface 1320 comprises a wireless antenna. In otherembodiments, output interface 1320 comprises an electrical connector,such as a universal serial bus. Output interface 1320 may furthercomprise an RFID transmitter. Output interface 1320 may further includea wireless link (e.g., WiFi, Bluetooth®, IR, RF, or other known wirelesscommunication approaches, a direct wired connection (e.g. electricalwire or optical cable), or a direct connection via one or more directlead contacts. Thus, output interface 1320 facilitates communicationbetween disinfection device 1300 and a remote computer device, wherebyinformation obtained by and stored on memory of disinfection device 1300may be transferred to a remote computer device for long-term storage.

Input and output interfaces 1310 and 1320 may be located at any positionon the housing of disinfection device 1300. In some embodiments, inputand output interfaces are positioned such that a user may holddisinfection device 1300 in their hand and still have access to theinterfaces. Input and output interfaces 1310 and 1320 may furthercomprises a separate device that is operably connected to disinfectiondevice 1300 via a corded or wired connection, or a wireless connection.For example, input interface 1310 may comprises a wireless antenna thatreceives a signal from barcode scanner that is wirelessly connected toinput interface 1310.

Referring now to FIG. 14, a cross-section view of disinfection device1300 is shown. In some embodiments, input and output interfaces 1310 and1320 are operably connected to the remaining components and circuitry ofdisinfection device 1300 via printed circuit board 160. Needlelessconnector 120 may further comprises one or more computer-readable codes122 which may be scanned or otherwise read by input interface 1310 priorto commencing a disinfection event. In some embodiments, cleaning head108 further comprises a computer-readable code 124 which containsinformation related to the identity and history of cleaning head 108 toprevent multiple uses of the disposable component.

In some instances, information retrieved from codes 122 and 124 aretemporarily stored within memory of disinfection device 1300. The storedinformation may subsequently be transferred to a remote computer devicevia output interface 1320. In some embodiment, retrieved information istransferred to a remote computer device in real-time via outputinterface 1320. Input and output interfaces 1310 and 1320 may further beused to retrieve, record, and report information regarding the identityof a patient, wherein the patient information is contained in acomputer-readable format. In some instances, the processes of recordingand reporting the retrieved information is automatic, therebyeliminating user error.

In some embodiments, information regarding the identity of the patientand/or the needleless connector is entered manually into disinfectiondevice 1300 or a remote computer device. For example, disinfectiondevice 1300 may include a keyboard. Disinfection device 1300 may furtherinclude a microphone and transcription software, whereby a clinician mayaudibly enter information into disinfection device 1300. Disinfectiondevice 1300 may further be operably connected to a separate inputdevice, whereby the clinician is able to input information intodisinfection device 1300 via the separate input device.

In some embodiments, the process of detecting a disinfection status,tracking a disinfection event, recording the disinfection event, andreporting the disinfection event may ensure compliance to propercleaning procedures, thereby helping the clinical outcomes for patientsand care providers. This information may further be stored in anelectronic medical record (EMR) of the patient. As such, thedisinfection event becomes part of the patient's medical history whichmay be accessible to other physicians and clinicians to assist intreatment of the patient. The information may further be accessed aspart of an audit proceeding, such as a safety compliance audit. Thisinformation may further be accessed to assess areas, methods andtechniques that may need revision to increase the quality and/orconsistency of patient care.

Referring now to FIG. 15, in some embodiments disinfection device 1300is operably connected to a network 38 via a hardwired and/or wirelesslink 350. In some embodiments, link 350 comprises a portion of outputinterface 320. When information is acquired by disinfection device 1300,the information is transmitted to network 38 where the information ismade accessible to various remote computer devices also operablyconnected to network 38. Further, in some embodiments acquiredinformation is stored in a database, such as an EMR 360.

EMR 360 generally comprises a computerized medical record for a patient,as known in the art. In some embodiments, EMR 360 is configured toreceive and store information relating to the disinfection event. Forexample, EMR 360 may receive information such as the date of thedisinfection event, a final status of the disinfection event, theidentity of the clinician who performed the disinfection event, theidentity of the needleless connector, as well a time and/or duration ofthe disinfection event.

Network 38 may include a server on which a computer executable programis loaded having instructions for receiving, analyzing, and storinginformation received from disinfection device 1300. Network 38 mayfurther include network security software or other precautionarysoftware as may be required to comply with Health Information PatientPrivacy Act requirements. In some embodiments, network 38 comprises alocal area network. In other embodiments, network 38 is a global areanetwork.

In some configurations, disinfection device 1300 is operably connectedto network 38 via a processor unit 1670 or other computer system, asshown in FIG. 16. Processor unit 1670 receives and processes retrievedinformation from output interface 1320 prior to storing the informationin EMR 360. Processor unit 1670 may include any type or form ofcomputing device which is compatible with the teachings of the presentinvention. In some embodiments, processor unit 1670 comprises a tabletcomputer. In other embodiments, processor unit 1670 comprises a desktopcomputer. Processor unit 1670 may further comprise a mainframe computer.Further still, in some embodiments processor unit 1670 comprises amobile smart device, such as a smartphone, a tablet computer, orpersonal digital assistant device.

Referring now to FIG. 17, disinfection device 1300 may include varioussystems and/or methods by which information relating to needlelessconnector 120 may be collected and reported. For example, in someembodiments disinfection device 1300 comprises input and outputinterfaces 1310 and 1320 which are capable of scanning a barcode 122 ofneedleless connector 120. Input and output interfaces 1310 and 1320 mayfurther scan a barcode 128 of an IV fluid bag 121 coupled to needlelessconnector 120. In some instances, needleless connector 120 comprises anRFID chip 126. Accordingly, disinfection device 1300 may include an RFIDreader. Disinfection device 1300 may further include an RFID transmitterwhereby to report retrieved information to a computer device comprisingan RFID receiver.

Input interface 1310 may further comprise a microphone 1330 wherebyinformation is input by speaking the information into microphone 1330.The information may subsequently be reported or transferred to a remotecomputer device by any of the various output interfaces 1320 with whichdisinfection device 1300 is equipped. Accordingly, various embodimentsof the present invention provide a disinfection device having one ormore input interfaces 1310 and one or more output interfaces 1320,whereby information is retrieved by one or more of the input interfaces1310 and subsequently transferred to a remote computer device via one ormore of the output interfaces 1320.

Referring now to FIG. 18, a method for monitoring, recording, andtracking disinfection information is shown. In some embodiments, adisinfection device of the present invention is configured to generateand store information regarding a disinfection status of a needlelessconnector that is being disinfected as part of a disinfection event (atstep 1800). The disinfection device further comprises an input interfacewhich is configured to receive an identification of the needlelessconnector (at step 1802). In some instances, the identification of theneedleless connector is retrieved prior to commencing disinfection ofthe needleless connector. In other instances, the identification of theneedleless connector is retrieved following a disinfection event.

The disinfection status and identity of the needleless connector arethen sent to a remote computer system (at step 1804). The retrievedinformation is then stored in an electronic medical record of thepatient for whom the needleless connector was disinfected (at step1806).

Referring now to FIG. 19, a method for monitoring and recording adisinfection event of a needleless connector is shown. In someembodiments, a method for monitoring a recording a disinfection event ofa needleless connector comprises a first step of attaching a disposablecleaning head to a rotor of a disinfection device (at step 1900). Insome embodiments, a clinician first uses an input interface of thedisinfection device to retrieve information from the cleaning head whichrelates to the identity and history of the cleaning head. By trackingthe disposable cleaning or disinfection head used in the disinfectionprocess or event, a clinic may ensure that the disinfection or cleaninghead has only been used once. Thus, cross-contamination between thecleaning head and subsequent needleless connectors is avoided.

The clinician then uses the disinfection device to retrieve and recordinformation relating to the identity of the patient and/or theneedleless connector (at step 1902). The clinician then disinfects theneedleless connector using the disinfection device (at step 1904). Insome embodiments, the disinfection device automatically records of thedisinfection event, as well as other information relating to thedisinfection event (at step 1906). For example, the disinfection devicemay automatically record error messages, date and timestamp information,and the identity of the clinician performing the disinfection event. Therecorded information is then transferred to a remote computer devicewhich processes the information and uploads the information to anelectronic medical record (at step 1908).

The present invention may be embodied in other specific forms withoutdeparting from its structures, methods, or other essentialcharacteristics as broadly described herein and claimed hereinafter.Thus, the described embodiments are to be considered in all respectsonly as illustrative, and not restrictive. The scope of the inventionis, therefore, indicated by the appended claims, rather than by theforegoing description. All changes that come within the meaning andrange of equivalency of the claims are to be embraced within theirscope.

The invention claimed is:
 1. A disinfection system, comprising: aneedleless connector; a disinfection device, comprising: a motor; amotor shaft; a hub coupled to the motor via the motor shaft, wherein themotor rotates the motor shaft and the hub; a rotating cleaning headapparatus coupled to the hub and comprising a cleaning pad and a body,wherein the body comprises an outer surface and a distal opening,wherein the distal opening forms an inner chamber capable of receivingthe needleless connector, wherein the inner chamber is lined with thecleaning pad; a speed sensor that monitors and measures an axialrotation speed of the hub, wherein in response to measuring the axialrotation speed of the hub below a minimum axial rotation speedthreshold, the speed sensor generates an error code; a status indicator;a status indicator controller, wherein the status indicator controllerreceives the error code, wherein in response to the status indicatorcontroller receiving the error code, the status indicator controllersends a signal to the status indicator displays a color or a lightedpattern; and a timer electrically coupled to the speed sensor, whereinthe timer measures a length of time for the hub to reach the minimumaxial rotation speed threshold, the minimum axial rotation speedthreshold being measured by the speed sensor, wherein in response tomeasurement of the minimum axial rotation speed above the minimum axialrotation threshold for a minimum time lapse threshold, the statusindicator displays another color or another lighted pattern.
 2. Thedisinfection system of claim 1, wherein the cleaning pad is preloadedwith a cleaning agent.
 3. The disinfection system of claim 1, whereinthe cleaning pad is capable of receiving a cleaning agent prior to thecavity receiving the needleless connector.
 4. The disinfection system ofclaim 1, wherein the outer surface comprises one or more attachmentfeatures configured to selectively couple the cleaning head apparatus tothe hub such that the cleaning head apparatus rotates with the hub,wherein the one or more attachment features comprises a post, whereinthe hub comprises a receptacle configured to receive and retain thepost.
 5. The disinfection system of claim 1, wherein a proximal endcomprises an attachment feature configured to selectively attach thecleaning head apparatus to the motor capable of rotating the cleaninghead apparatus, wherein the attachment feature comprises a singleannular indent forming a groove.
 6. The disinfection system of claim 1,wherein a proximal end comprises an attachment feature configured toselectively attach the cleaning head apparatus to the motor capable ofrotating the cleaning head apparatus, wherein the attachment featurecomprises a magnet.
 7. The disinfection system of claim 1, wherein thecleaning head apparatus is disposable.
 8. The disinfection system ofclaim 1, wherein the cleaning head apparatus is reusable.
 9. Thedisinfection system of claim 1, further comprising an absorbent materialinterposed between the cleaning pad and the inner chamber, wherein theabsorbent material is impregnated with a cleaning agent.
 10. Thedisinfection system of claim 1, wherein the inner chamber comprisestapered walls.
 11. The disinfection system of claim 1, furthercomprising a computer-readable code positioned on the outer surface ofthe body and which contains information related to the identity andhistory of the apparatus.
 12. A method for manufacturing the cleaninghead apparatus of claim
 1. 13. The disinfection system of claim 1,wherein a proximal end of the cleaning head apparatus comprises anattachment feature configured to selectively attach the cleaning headapparatus to the motor capable of rotating the cleaning head apparatus,wherein the attachment feature comprises one or more indents spacedradially about an exterior of the body.
 14. A method for cleaning aneedleless connector using the cleaning head apparatus of claim 13, themethod comprising steps for: attaching the cleaning head to the motorvia the attachment feature; inserting the needleless connector into theinner chamber; and rotating the cleaning head via the motor whilemaintaining the inserted position of the needleless connector within theinner chamber.
 15. The method of claim 14, further comprising a step forpreloading the cleaning cloth with a cleaning agent prior to insertingthe needleless connector into the inner chamber.
 16. The method of claim14, further comprising a step for removing the needleless connector fromthe inner chamber after the needleless connector is disinfected.
 17. Themethod of claim 16, further comprising a step for disposing the cleaninghead apparatus after the step removing the needleless connector from theinner chamber.